Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Vivachek Biotech (Hangzhou) with 11 510(k) clearances. The most recent is a 510(k) clearance dated Oct 9, 2026: VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose an….
510(k) clearances: 11
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
02017Records0
020182018Records0vs 2017+0
02019Records0vs 2018+0
120202020Records1vs 2019+1
02021Records0vs 2020−1
120222022Records1vs 2021+1
32023Records3vs 2022+2
320242024Records3vs 2023+0
12025Records1vs 2024−2
220262026 to dateRecords2
Latest Records
Newest first across sources; each opens the record
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
